This observational cohort study evaluates the safety and effectiveness of minimally invasive surgery (MIS) compared with standard medical management in adults with spontaneous deep intracerebral hemorrhage. Consecutive patients admitted to People's Hospital 115 and Tam Anh General Hospital will be enrolled within 72 hours of onset. Clinical and imaging data will be collected prospectively, and outcomes including survival and functional status will be assessed through 180 days.
Spontaneous deep intracerebral hemorrhage (ICH) is associated with high early mortality and long-term disability. Conventional craniotomy has not consistently improved functional outcomes, while medical management alone often results in poor prognosis. Minimally invasive surgery (MIS), including parafascicular approaches guided by neuronavigation, is designed to evacuate hematomas with reduced disruption of critical white-matter tracts. Evidence supporting MIS is more robust in lobar ICH, whereas data for basal ganglia hemorrhage remain limited. Furthermore, most prior studies restricted surgical intervention to within 24 hours from onset, leaving uncertainty regarding potential benefit when performed between 24 and 72 hours. This prospective, multicenter, observational cohort study is conducted at People's Hospital 115 and Tam Anh General Hospital. Consecutive patients admitted with spontaneous basal ganglia ICH are enrolled within 72 hours of onset. Decisions regarding MIS, including whether to operate and the timing of surgery, are made by treating clinical teams in routine practice. The study does not assign interventions but documents real-world management and outcomes. Data are captured prospectively using standardized CRFs and electronic CRFs. Information includes demographics, comorbidities, presenting neurological status, laboratory and imaging findings, details of MIS when performed, intensive care and hospital course, and follow-up assessments through 180 days. The primary endpoint is functional outcome at 180 days, while safety endpoints include mortality and treatment-related complications. Analyses are planned using prespecified multivariable approaches to account for confounding by indication. Additional subgroup analyses will assess outcomes by timing of MIS (0-24 vs 24-72 hours) and other clinically relevant variables. By focusing on basal ganglia hemorrhage in contemporary Vietnamese stroke centers, this study is intended to generate real-world evidence on the effectiveness and safety of MIS in deep ICH and inform selection criteria and timing for future interventional trials.
Study Type
OBSERVATIONAL
Enrollment
300
People's Hospital 115
Ho Chi Minh City, Ho Chi Minh, Vietnam
RECRUITINGPrimary Outcome Measure 1 - Efficacy: Functional Outcome by Modified Rankin Scale (mRS)
Proportion of participants achieving favorable functional outcome defined as mRS 0-3. Unit of Measure: Percentage of participants
Time frame: 180 days after intracerebral hemorrhage
Primary Outcome Measure 2 - Efficacy: Functional Outcome by Utility-Weighted mRS (UW-mRS)
Mean UW-mRS score at 180 days after intracerebral hemorrhage. The UW-mRS is a continuous, utility-weighted measure of functional outcome ranging from 0 (death) to 1 (no symptoms). Unit of Measure: Score (0-1 scale)
Time frame: 180 days after intracerebral hemorrhage
Primary Outcome Measure 3 - Safety: All-Cause Mortality
Number of participants who die from any cause within 30 days after intracerebral hemorrhage. Unit of Measure: Percentage of participants
Time frame: 30 days after intracerebral hemorrhage
Primary Outcome Measure 4 - Safety: Procedure-Related Complications
Incidence of major complications related to minimally invasive surgery or medical management, including but not limited to rebleeding, infection, seizures, or other serious adverse events as judged by the investigators. Unit of Measure: Number of participants with complications
Time frame: Within hospitalization and up to 30 days after intracerebral hemorrhage
Secondary Outcome Measure 1: Functional Outcome by Timing of MIS (0-24 Hours vs 24-72 Hours)
Proportion of participants achieving favorable functional outcome (mRS 0-3) at 180 days, compared between patients undergoing minimally invasive surgery (MIS) within 0-24 hours and those undergoing MIS within 24-72 hours after intracerebral hemorrhage. Unit of Measure: Percentage of participants
Time frame: 180 days after intracerebral hemorrhage
Secondary Outcome Measure 2: All-Cause Mortality at 30 Days by Timing of MIS (0-24 Hours vs 24-72 Hours)
All-cause mortality within 30 days, compared between participants undergoing MIS within 0-24 hours versus 24-72 hours after intracerebral hemorrhage. Unit of Measure: Percentage of participants.
Time frame: 30 days after intracerebral hemorrhage
Secondary Outcome Measure 3: Procedure-Related Complications by Timing of MIS (0-24 Hours vs 24-72 Hours)
Incidence of major procedure-related complications (e.g., postoperative rebleeding, surgical site infection, CSF leak, clinically significant seizures) during index hospitalization and through 30 days, compared between participants undergoing MIS within 0-24 hours versus 24-72 hours. Unit of Measure: Number of participants with ≥1 complication
Time frame: Within hospitalization and up to 30 days after intracerebral hemorrhage
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